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Nonclinical Study Optimization Initiative

Rationale

Vision

Seeking efficiencies for Contract Research Organizations (CROs), Sponsors, and other stakeholders, the BioCelerate Nonclinical Study Optimization Initiative is focused on two ideas, working towards the development of common toxicology study protocol and report templates and the development of recommendations for implementation of CDISC SEND data packages focused on facilitating cross-study comparisons.

The scope of this initiative is twofold:

  1. Develop a baseline template and terminology/language guidelines for general toxicology / safety pharmacology study protocols and reports. These open-source documents are intended to be used by CRO partners and Sponsors to improve operational efficiencies and data quality.
  2. Develop an open-source SEND implementation companion guide intended for use by CROs and Sponsors that is designed to allow cross study comparison of SEND formatted data.

Unmet Needs

  • CROs are currently required to adhere to a wide array of Sponsor-specific protocol and/or report templates, often introducing errors and a lack of consistency in study conduct, data quality, and increased work and delay, because information is not in a consistent place.
  • The current version of the CDISC SEND format allows a level of flexibility within its current implementation guidelines that, while resulting in compliant data packages, introduces variations rather than adherence to a common format. This variability results in inconsistent SEND data and report content produced by CRO partners, making cross-study comparisons difficult without Sponsor resources further harmonizing the data upon receipt.

Benefits

Common Templates

  • A common protocol template will potentially:
    • Decrease CRO and investigator time spent looking for key content;
    • Decrease study errors and improve data quality, with the potential to lead to reductions in animal usage due to fewer studies having to be repeated.
    • Lead to more rapid protocol development, allowing studies to get started more quickly.
  • A common report template will potentially:
    • Allow reports to be written more quickly- resulting in more rapid data delivery and speeding up development timelines.
    • Lead to the development of automation opportunities further improving efficiency and decreasing cycle times.

SEND Implementation Guideline

  • The SEND implementation guideline will enable:
    • Organizations more easily to compare data generated across studies and across CROs, leading to decreased cycle times and more informed decision making.
    • Allow CROs to generate more efficient processes to deliver data leading to decreased cycle times.
    • Reduce the need to develop and maintain internal SEND standards, companies will save resources.
    • Quality improvements in the data sets due to fewer one-off and custom changes that can lead to errors.
    • Reduction in rework.

Available Assets

Over the next few months, an analysis will be conducted to determine gaps and understand impact with a focus on determining the primary drivers of variability for protocols and SEND data sets. During Q1 2019, the team plans to share initial results of this work with key stakeholders and work with them to develop potential solutions for implementation in 2019.